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Medcon 2023 Horz Fda

MedCon Conference 2023

Since 2009, MedCon has united regulators and healthcare products industry experts for unparalleled exchanges.

For the first time since 2019, MedCon reunited in-person April 24-27, 2023 for three days of purpose-driven discussions that harmonize different perspectives to inspire collaboration, lead innovation, and make a difference in patient care. The event was hosted by the AFDO/RAPS Healthcare Products Collaborative and co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services.

if YOU MISSED THIS YEAR’S MEDCON, here’s what we covered —

MedCon 2023 by the #s






FDA speakers








FDA participants



…and 14 countries across 5 continents

An experience like no other!

Full-day risk management pre-conference workshop and two-and-a-half-day, in-depth Conference

Paradigm-shifting dialogue leading to practical solutions that can be implemented immediately

Proactive and predictive methods to protect products, businesses, and patients

Cross-functional insights that fostered critical alignment and collaboration across organizations

Gina Brackett, OMDRHO Division 1 Director, Compliance Branch and MedCon Co-Chair, FDA-ORA
“The MedCon Conference helps fulfill the Department of Health and Human Servcies’ and FDA’s important mission to protect public health.”

Gina Brackett

Director, Compliance Branch FDA ORA Office of Medical Device and Radiological Health

Past Program Lineup

Our 2023 lineup enabled attendees to engage and contribute in plenaries aimed at breaking barriers and solving problems, along with in-depth breakouts and the Solutions Exchange!

Sessions included:

  • Returning to the New Normal in the Face of Evolving Challenges: Update from CDRH Director, Jeff Shuren
  • Medical Device User Fee Amendment (MDUFA) V: How Is It Impacting FDA Staff, Industry, and Patients?
  • Office of Regulatory Affairs (ORA) Office of Medical Device and Radiological Health Update
  • Finding Common Ground: Managing Device Interoperability Expectations
  • Situation in UK & Switzerland
  • Sustainability Throughout the Supply Chain: FDA and Industry Perspectives
  • FDA Transition to ISO 13485/Update on Proposed Rule Aligning QSR With 13485 (QMSR)
  • Global Regulatory Convergence and Shaping Innovation
  • Innovating Submission of Premarket Applications – CDRH Portal and eSTAR Program
  • Demonstration of FDA Databases and Publicly Available Tools

Past Speaker Highlights

Jeff Shuren, Director of the Center for Devices and Radiological Health, FDA-CDRH

Jeff Shuren

Director of the Center for Devices and Radiological Health (CDRH), FDA

Elizabeth Miller

Assistant Commissioner for Medical Products and Tobacco Operations, FDA-ORA

Monica Wilkins

Vice President Regulatory and Quality, Abbott

Sabina Hoekstra-van den Bosch

Global Director Regulatory Strategy, TÜV SÜD Medical Health Services

Kim Trautman, Managing Director and VP, MEDIcept

Kim Trautman

Managing Director and Vice President, MEDIcept Inc.

Keisha Thomas, Associate Director for Compliance and Quality, FDA - CDRH

Keisha Thomas

Associate Director for Compliance and Quality, CDRH, FDA

Douglas Kelly

Deputy Center Director for Science Office of the Center Director, CDRH, FDA

Phil Pontikos, Investigator, Medical Device National Expert, FDA-OMDRHO-ORA

Phil Pontikos

National Expert, OMDRHOORA, FDA (Invited)

Heather Rosecrans, Executive Vice President, Medical Devices & Combination Products, Greenleaf Health Vice President Regulatory Affairs, MDMA

Heather Rosencrans

Executive Vice President, Medical Devices & Combination Products, Greenleaf Health
Vice President Regulatory AffairsMDMA

RAPS Regulatory Affairs Certificate (white)

MedCon attendees were able to earn 12.0 RAC recertification credits. 

Past Sponsors

Because of the generosity of our sponsors, we can continue our work to improve the healthcare products industry.

Diamond Sponsor

Platinum Sponsor

Platinum Sponsor

Gold Sponsor

Gold Sponsor

Gold Sponsor

Proctor and Gamble Logo

Gold Sponsor


Silver Sponsor


Learn more about supporting MedCon through sponsorship by contacting Patrick Flynn at 301-770-2920, ext. 246 or

This conference is co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.


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© 2024 AFDO/RAPS Healthcare Products Collaborative